Cabrini Medical Center of New York City and University of California, Irvine (UCI) Cardiovascular Imaging Center, have selected the ImageGrid 1000 as their dedicated image management and Picture Archiving and Communication System (PACS) for high-capacity cardiac 64-slice computed tomography (CT) imaging.

Candelis' ImageGrid is a line of fully-integrated, Digital Imaging and Communications in Medicine (DICOM) industry-standard PACS appliances that speed digital image access and routing, simplify image management, and provide highly reliable storage and archive capabilities.

Medtronic, Inc. has the FDA’s approval to initiate the Feasibility of the Lone Atrial Fibrillation Clinical Trial (FACT), which coincides with the launch of Medtronic’s Cardioblate Navigator Tissue Dissector.

Toshiba America Medical Systems, Inc. held a grand opening Wednesday of the new Toshiba Education Center, a $6 million, 4,840 square-foot expansion to the Toshiba Training Academy that provides a full complement of state-of-the-art classrooms and labs equipped with Toshiba’s advanced CT, MR and Vascular products, including the Aquilion, Vantage and Infinix systems.

All Toshiba customer training will now take place at the center, as well as at institutions across the U.S., while Toshiba Service training continues at the Training Academy.

New tachycardia software for the Merlin Patient Care System by St. Jude Medical has received FDA approval. The software upgrade utilizes a state-of-the-art computer to program and interrogate cardiac rhythm management devices like pacemakers and implantable cardioverter defibrillators (ICDs).

Thoratec has announced it has filed the first two modules of its Pre-Market Approval to market its HeartMate II for bridge-to-transplantation (BTT).

The company says that of October 26, 2006, it had implanted a total of 416 patients in its Phase II pivotal trial for the next generation assist device, enrolling 97 patients during the past three months, including a record 48 patients in the Destination Therapy arm.

The American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) says it will launch a new initiative on Jan. 7, 2007, to improve safety and outcomes for patients with Acute Coronary Syndrome (ACS). The initiative will combine the data collection and quality reporting features of two leading national ACS registries to create the largest and most comprehensive national cardiovascular patient database ever developed.

The first patient of the PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) U.S. pivotal study has been enrolled by Dr. Naveen Sachdev from Providence St. Vincent's Hospital in Portland, Oregon. The study is designed to determine the safety and efficacy of the CROSSER 14 and CROSSER 18 Catheters by FlowCardia for CTO recanalization in the upper and lower legs.

An initial review of the premarket approval application for the ATS 3f(R) Aortic Bioprosthesis Heart Valve has been completed by The Center for Devices and Radiological Health FDA.

The ATS 3f(R) brand — by ATS Medical, Minneapolis, MN — encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology.

Company chairman and president says it’s an important milestone along the path to U.S. market approval of the device.

The FDA has cleared Boston Scientific’s NexStent Carotid Stent and Monorail Delivery System for use in patients with carotid artery disease who are at high risk for surgery. The NexStent Carotid Stent is manufactured by EndoTex Interventional Systems, Inc. and has been distributed exclusively by Boston Scientific outside the U.S. since receiving European CE Mark in 2005.

Stereotaxis has received FDA 510(k) clearance for its Niobe magnetic navigation system for use in neurovascular and peripheral applications with the company's family of Cronus magnetically enabled .014" vascular guide wires. The Niobe System and Cronus guide wires were previously cleared for coronary vasculature procedures only.

The Cronus guide wire family will now integrate with the Niobe magnetic navigation system to provide precise magnetic guide wire navigation in coronary, neurovascular and peripheral anatomy, according to a company press statement.

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